RESOLUTION – RDC No. 211, OF JANUARY 22, 2018
It provides for the validity period of the registration of medical devices.
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It provides for the validity period of the registration of medical devices.
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Regulates RDC 36/2015. Criteria for family grouping of in vitro diagnostic products.
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Defines "product group" to which item 5.3 of Annex II of Law 9,782 of January 26, 1999 applies.
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Establishes the specific criteria for the grouping into families of materials for use in health for the purposes of registration and notification.
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It provides for the procedures for compulsory certification of equipment under the Sanitary Surveillance regime.
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